KARTHIK NADAKUDITI
Newark
Summary
A total of 19 years’ of focused education, research and experience in life sciences with strong fundamentals in Clinical Data Management practices. Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent vendor relations aptitude and relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance.
Overview
14
14
years of professional experience
Work History
Director, Data Management
Alumis
07.2023 - Current
- Program and vendor oversight for Lupus and Uveitis projects
- Developed high-performing teams by providing mentorship, guidance, and opportunities for professional growth.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
- Developed key Data Management processes to support the pivotal Phase 3 trials by collaborating with cross functional team and external data partners.
Director, Clinical Data Management
ChemoCentryx (Acquired by Amgen)
08.2022 - 06.2023
- Department lead for CCX559, Avacopan PK and DDI studies.
- Engaged in establishing and maintaining vendor DM relationship for data deliverables and overall program success
- Responsible for seamless database change management, vendor collaboration and site training
- Involved in oncology CRF review and CRF design updates based on solid oncology experience
- Responsible for start-to-end oversight of DM vendor for all Data management process and data deliverables.
- Responsible for authoring departmental SOPs, oversight of database development, data review, quality review, data management documentation, audit readiness and timely submission of data deliverables
Associate Director, Head of Data Management
Vincerx Pharma
04.2021 - 07.2022
- Led the department of Data management through key data management processes, their implementation and change management
- Responsibly ensured that the day-to-day data management activities met the needs of the study team
- Implemented CDASH standards while designing the CRFs to ensure seamless data extraction and SDTM formatting for statistical programming
- Spearheaded VIP-152 program targeting DLBCL and gynecologic malignancies from Data management front
- Ensured optimum utilization of program resources by leveraging in-house skills and capabilities against the contracted vendors
- Supported submission of abstracts to key conferences such as ASCO and AARC
- Drafted key departmental Standard Operating Procedures and work instructions to ensure seamless data capture, review and extraction in clinical studies
- Actively involved in EDC builds, systems integrations, migrations, UATs and deployments
- Thoroughly validated data systems that are within the scope of 21 CFR part 11 compliance
- Supported medical coding needs of the study by manually coding the terms using MedDRA and WHODRUG dictionaries, which are otherwise not autocoded.
Senior Manager, Data Science and Systems
Nektar Therapeutics
08.2020 - 04.2021
- Data management oversight for Nektar's immuno-oncology program, NKTR-255
- Study lead for solid tumor programs involving Colorectal and Head/Neck cancers
- Performed extensive vendor management involving IRT, Safety labs, Biomarkers, Immunogenicity, PK and Imaging, to support the data needs for the studies responsible
- Actively supported the development of SOPs for study build and IRT integration by educating Nektar leadership on process related efficiencies pertaining to integrating systems
- Performed vital study build activities including, but not limited to, authoring eCRF specifications, edit check specifications/custom functions, folder dynamics, implementation of CDASHIG v2.1 and CDISC terminology
- Assisted in development, testing and launch of Nektar's home built macro-based URS tool called MEDUSA for standards and acceptance
- Authored and executed study DMP and CCGs within 6 weeks of database go-live
- Challenged and collaborated with cross functional teams to troubleshoot key issues pertaining to standards implementation and their impact on data analysis
- Proficiently produced study related BO4 reports for team's review before the DRP listings were programmed for review.
Manager, Clinical Data Management
Gilead Sciences
03.2020 - 07.2020
- Led the transition of solid tumor studies to Gilead systems and processes
- A thorough understanding of the data management integration processes during the M&A activity, especially in terms of transition of standards and quality plans across existing programs
- Effectively assisted with horizontal integration where staggered integration process is followed during M&A activity
- Thorough review of departmental SOPs, DOPs and other data management documents such as DMP, DQRP etc
- Hands on experience with building integration timelines without compromising on key deliverables mandated for the study
- Effectively transitioned studies from RAVE-classic built by Medidata solutions to in-house Gilead programmers
- Lead the database integration with Suvoda IRT and Safety database.
Manager, Clinical Data Management
Forty Seven Inc (Acquired by Gilead)
11.2017 - 03.2020
- Led solid tumor program for Forty Seven's immunotherapeutic agent, Magrolimab
- Extensive vendor oversight of the first-in-human studies involving multiple histologies
- Led Data management activities for two studies from conduct to close out and one study from preclinical to start up
- Involved in the vendor selection process by providing inputs and insights to the oversight director
- Project management involving drafting timelines, planning the study milestones and stake holder analysis to meet the study timelines
- Generated reports for the study team using Business Objects 4.0 when there was minimal programming support
- Effectively collaborated with cross functional teams to review and clean the data for interim database locks, abstract submissions and presentations
- Authored and developed departmental SOPs, DMPs and DRPs
- Introduced process related efficiencies in the Data management processes such as external data reconciliations, Safety data reconciliations and periodic data reviews
- Built data listings and reports in collaboration with programming vendors to support data review and data quality.
Sr Clinical Data Manager
Acerta Pharma (Acquired by AstraZeneca)
11.2014 - 11.2017
- Data Manager for three Phase II Oncology Studies and one Phase III B-cell malignancy study
- Extensive vendor management from Study start up to Close out
- Involved in selection process of Vendors, establishing Data management expectations and oversight of all vendors activities pertaining to the study
- Collaborated with the offshore teams and cross-functional teams for efficient management of the study
- Developed project timelines and ensured the deliverables are produced within the timeline
- Involved in all the study build activities from protocol review to database go-live
- Authored, developed and executed departmental SOPs and audit potential documents, such as DMP, DRP and DTA
- Archived data management documents in a systematic and logical manner by adhering to DIA recommendation
- Achieved overall command over Oncology Data collection and handling
Sr Clinical Data Manager
Abbott Vascular
08.2013 - 10.2014
- Led and supported data management activities for four clinical trials in different phases of Build, conduct and close-out
- Oversaw data management activities from study build to database lock
- Hands on experience with developing departmental SOPs, DOPs and study related documents such as DMP, DRP, Study boards, DTAs, CRF specifications, edit check specifications, integrations specifications and report specifications
- Performed SAE reconciliation and External Lab data reconciliation per the frequency specified in the DMP
- Review, update and Archive standard data management templates
- Meet with Clinical Quality to check the regulatory compliance of the data management activities on regular basis.
Research Assistant
New York Methodist Hospital
11.2012 - 08.2013
- IRB approved research assistant at New York Methodist hospital, department of endocrinology
- Review of the Protocol designed and developed by LIU
- Understanding and developing the ICF for the study
- Explaining the potential study subjects, the study, informed consent and follow up parameters
- Patient education of Diabetes Mellitus Type 2 and the importance of regular physical activity
- Enrolled 50 patients in a study, “The Effects Of Simple Telecommunication Reminders On Improving Levels Of Physical Activity In Type 2 Diabetes Patients “
- Followed up the subjects in the study through phone calls and text messages
- Evaluated the responses through a rubric according to the protocol of the study.
Teaching Assistant
Long Island University
09.2011 - 10.2012
- Worked on Health Retirement Study (HRS) RAND data set to find the correlation between total of all assets (HwATOTA) and depression with SAS 9.1
- Designed a clinical trial (procedure and protocol formation): Does Home visits during and after pregnancy reduce the consumption of alcohol?
- Pharmacoeconomic analyses of various treatments for Diabetes Type II
- Derived plausible explanation of different dependent and independent variables affecting weight loss in obese population even after counting calories in the diet.
Research Analyst
GlobalData
07.2010 - 08.2011
- Study of pipeline drugs and their trends in pharmaceutical market
- Profiled more than 1000 clinical trials with concentration on Oncology and Cardiovascular drugs using secondary search techniques to find the missing trial results
- Worked on clinical trials registries (Clinicaltrials.gov, umin.com, ntr.com, azd.az.gov etc)
- Interview Principal Investigators for missing trial results, opinion on drugs and regulatory issues (such as rejections by FDA and suspension or termination of clinical trials)
- One year of experience in market research and analysis of Cardiovascular and Oncology drugs
- Safe Administration Of Paracetamol To Alcoholics: Worked on CYP450 insilico and recognition of cherachin as a probable binder that can restore glutathione residues
- Novel Periodontal Drug Delivery Systems
- DNA sequence analysis and making inferences from phylogenetic tree and cladograms using BLAST and FASTA: Insulin (Sus Salvanius).
Education
MBA -
Hutton School of Business
Master of Science - Pharmacy Administration and Policy
Long Island University
Bachelor of Pharmacy -
Osmania University
Skills
- Data Management Skills: Development of data management processes and standards from start up to close out, systems integration, vendor management, overall project management, TMF archival, development of reports for data review and reconciliation and audit ready GDMP
- Other tools and softwares: MS office package, C, C, BASIC, Html, SQL, AutoDock, BLAST, FASTA, EDGE Utility, MEDUSA and SPSS
- EDCs: Veeva Vault CDMS, Classic RAVE, Medidata Rave X, Express 53 and 54, ClinQuick, Entry Point, Celexus and Datatrak
Timeline
Director, Data Management
Alumis
07.2023 - Current
Director, Clinical Data Management
ChemoCentryx (Acquired by Amgen)
08.2022 - 06.2023
Associate Director, Head of Data Management
Vincerx Pharma
04.2021 - 07.2022
Senior Manager, Data Science and Systems
Nektar Therapeutics
08.2020 - 04.2021
Manager, Clinical Data Management
Gilead Sciences
03.2020 - 07.2020
Manager, Clinical Data Management
Forty Seven Inc (Acquired by Gilead)
11.2017 - 03.2020
Sr Clinical Data Manager
Acerta Pharma (Acquired by AstraZeneca)
11.2014 - 11.2017
Sr Clinical Data Manager
Abbott Vascular
08.2013 - 10.2014
Research Assistant
New York Methodist Hospital
11.2012 - 08.2013
Teaching Assistant
Long Island University
09.2011 - 10.2012
Research Analyst
GlobalData
07.2010 - 08.2011
MBA -
Hutton School of Business
Master of Science - Pharmacy Administration and Policy
Long Island University
Bachelor of Pharmacy -
Osmania University
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